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Fructans, Lactitol and Lactose in Minimal Hepatic Encephalopathy

Primary Purpose

Liver Cirrhosis

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Red cereal bar
Green cereal bar
White cereal bar
Sponsored by
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cirrhosis focused on measuring Minimal hepatic encephalopathy, Hepatic encephalopathy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged 18 to 70 years.
  • Liver cirrhosis of any etiology.
  • Presence of minimal hepatic encephalopathy.
  • Presence of hepatic encephalopathy I

Exclusion Criteria:

  • Hepatic encephalopathy II or III
  • Use of antibiotics in the previous month.
  • Presence of immunological diseases.
  • Consumption of probiotics.
  • Patients with hepato-renal diseases.
  • Patients who do not agree to participate in the project.

Sites / Locations

  • Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Red cereal bar

Green cereal bar

White cereal bar

Arm Description

It includes the intervention of the red cereal bar for the designation of the group.

It includes the intervention of the green cereal bar for the designation of the group.

It includes the intervention of the white cereal bar for the designation of the group.

Outcomes

Primary Outcome Measures

Minimal hepatic encephalopathy
Assessed by psychometric Hepatic Encephalopathy (PHES) and Critical Flicker Frequency (CFF)

Secondary Outcome Measures

Nutritional Status
Measured with the following parameters:body weight and height (to calculate BMI), triceps skinfold and mid-arm circumference (to calculate mid-arm muscle circumference, and bioelectrical impedance vector analysis.

Full Information

First Posted
December 16, 2013
Last Updated
June 7, 2016
Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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1. Study Identification

Unique Protocol Identification Number
NCT02022137
Brief Title
Fructans, Lactitol and Lactose in Minimal Hepatic Encephalopathy
Official Title
Evaluation of the Effect of a Cereal Bar With Added Agave Fructans or Lactitol or Lactose, in Patients With Minimal Hepatic Encephalopathy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
As an alternative for the treatment of Minimal Hepatic Encephalopathy (MHE) Agave fructans have shown prebiotic effects, and have shown to improve function of the digestive system, control and induce glycemic effect satiety. Therefore the impact of the fermentation of such prebiotic in the gut may contribute to improving health and quality of life of patients with MHE.
Detailed Description
Hepatic encephalopathy (HE) is a potentially reversible neuropsychiatric syndrome characterized by changes in cognitive function, behavior and personality of patients with chronic liver disease or cirrhosis. Increased concentration of ammonia is the main precipitant of encephalopathy and brain astrocytes are the main affected cells in the neuropathology of this disease. The toxicity of ammonia together with the neutrophil dysfunction and oxidative stress and inflammation secondary to infection, result in a progressive decline in quality of life and an increased risk of accidents for patients with this disease. About 28% of patients with liver cirrhosis develop encephalopathy during the course of the disease and within this percentage, 84% will develop MHE. Currently, chronic liver diseases are the third leading cause of death in Mexico. The high prevalence suggests that HE could become a public health problem, with the 2020 projected figures of 1.5 million people with cirrhosis, which represents approximately 400 000 to 500 000 people with probable encephalopathy. The usual treatment of MHE is the use of antibiotics or pro and prebiotics, these enhances the performance and quality of life of patients who have the disease. The general consensus has been using lactulose or lactitol as the first treatment options for MHE consistent with data from previous studies. However, the rate of adherence to treatment with lactulose and lactitol is low, especially in patients with MHE with no symptoms and lack of specific information about their problems, to adhere to medications that can cause diarrhea and flatulence. In the last eight years functional ingredients have been studied as alternatives to the treatment of patients with MHE. In 2004, Liu et al showed that 25% chicory inulin (prebiotic) and this combined with probiotics improve the psychometric function of MHE patients. In similar studies conducted in 2007 and 2009 in which they used a formulation with a symbiotic fructo-oligosaccharides based chicory inulin and B. longum, showed improvement in psychometric tests applied to patients. In 2008, Bajaj et al showed that patients who consumed a yogurt with probiotics, showed significant changes in the degree of MHE. As an alternative for treating the MHE we found Agave tequilana Weber fructans, which present prebiotic effect, besides having shown to improve the function of the digestive system, control and induce glycemic effect satiety. Therefore the impact of the fermentation of such prebiotic in the gut may contribute to improving the health and quality of life of patients with MHE.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis
Keywords
Minimal hepatic encephalopathy, Hepatic encephalopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Red cereal bar
Arm Type
Experimental
Arm Description
It includes the intervention of the red cereal bar for the designation of the group.
Arm Title
Green cereal bar
Arm Type
Placebo Comparator
Arm Description
It includes the intervention of the green cereal bar for the designation of the group.
Arm Title
White cereal bar
Arm Type
Active Comparator
Arm Description
It includes the intervention of the white cereal bar for the designation of the group.
Intervention Type
Dietary Supplement
Intervention Name(s)
Red cereal bar
Intervention Description
Consumption of the cereal bar with agave fructans or lactitol or lactose added each bar with 10 grams of dietary fiber and 1.2 grams of protein by weight and 20 to 30 grams of fiber.
Intervention Type
Dietary Supplement
Intervention Name(s)
Green cereal bar
Intervention Description
Consumption of the cereal bar with agave fructans or lactitol or lactose added each bar with 10 grams of dietary fiber and 1.2 grams of protein by weight and 20 to 30 grams of fiber.
Intervention Type
Dietary Supplement
Intervention Name(s)
White cereal bar
Intervention Description
Consumption of the cereal bar with agave fructans or lactitol or lactose added each bar with 10 grams of dietary fiber and 1.2 grams of protein by weight and 20 to 30 grams of fiber.
Primary Outcome Measure Information:
Title
Minimal hepatic encephalopathy
Description
Assessed by psychometric Hepatic Encephalopathy (PHES) and Critical Flicker Frequency (CFF)
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Nutritional Status
Description
Measured with the following parameters:body weight and height (to calculate BMI), triceps skinfold and mid-arm circumference (to calculate mid-arm muscle circumference, and bioelectrical impedance vector analysis.
Time Frame
2 months
Other Pre-specified Outcome Measures:
Title
Ammonia, liver function tests
Time Frame
baseline and 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18 to 70 years. Liver cirrhosis of any etiology. Presence of minimal hepatic encephalopathy. Presence of hepatic encephalopathy I Exclusion Criteria: Hepatic encephalopathy II or III Use of antibiotics in the previous month. Presence of immunological diseases. Consumption of probiotics. Patients with hepato-renal diseases. Patients who do not agree to participate in the project.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aldo Torre Delgadillo, M.D. M.Sc
Organizational Affiliation
INCMNSZ
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
City
México city
State/Province
D.f.
ZIP/Postal Code
1400
Country
Mexico

12. IPD Sharing Statement

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Fructans, Lactitol and Lactose in Minimal Hepatic Encephalopathy

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